SAN DIEGO, April 6 /PRNewswire/ -- Tragara Pharmaceuticals, Inc. today announced the completion of patient enrollment to its APRiCOT-L study, a phase II clinical trial of its oral, once-daily anti-cancer agent, Capoxigem® (apricoxib, TG01), in non-small cell lung cancer (NSCLC). The APRiCOT-L study is a randomized, double-blind, multi-center, placebo-controlled trial designed to evaluate Capoxigem in combination with erlotinib in second and third line NSCLC patients that have failed a platinum-containing regimen. Tragara is utilizing a biomarker in order to identify the patient population that will benefit most from Capoxigem therapy; biomarker response is an enrollment criterion for the study. The trial enrolled 128 patients and data from the study is expected to be available in Q3 2010.
“The completion of patient enrollment in this study is a significant milestone for Tragara and for the development of Capoxigem in several respects,” said Thomas M. Estok, president and chief executive officer, Tragara Pharmaceuticals, Inc. “We have validated that our approach to biomarker-based enrollment is operationally suitable and is not an impediment to expedient patient accrual. Additionally, we originally estimated that 70% of patients screened with the biomarker would be eligible for enrollment and we are pleased that actual eligibility exceeded that estimate.”
The primary efficacy endpoint of the APRiCOT-L study is to compare the time to progression (TTP) between the Capoxigem/erlotinib arm and the placebo/erlotinib arm. Secondary objectives include progression-free survival, response rate, duration of response, overall survival and measures of symptom relief.
Tragara conducted a phase I trial of Capoxigem and erlotinib in NSCLC to establish the Capoxigem dose regimen for optimal biomarker response with acceptable safety; the combination was well tolerated. In addition to the NSCLC phase II study, Tragara is conducting a randomized, placebo-controlled phase II study of Capoxigem in pancreatic cancer, in combination with gemcitabine and erlotinib, and is supporting an investigator initiated study of Capoxigem in NSCLC in combination with chemotherapy.
“Both preclinical and clinical research have demonstrated that modulation of the cyclooxygenase pathway can inhibit tumor growth in a variety of cancers including non-small cell lung cancer, breast cancer, and head and neck cancer,” said Sara Zaknoen, M.D., chief medical officer, Tragara Pharmaceuticals, Inc. “There is a significant need for treatment advances in cancer therapy, and Capoxigem holds promise for a potential new approach. We are particularly excited about selecting patients, based upon our biomarker, who are likely to receive the most benefit from Capoxigem.”
In support of Tragara’s personalized medicine approach to the development of Capoxigem, the Company is developing a “theranostic” product: ProGEM™, a proprietary diagnostic kit for the biomarker evaluated as part of the clinical trials. The Company plans to conduct phase III clinical trials using ProGEM for patient selection, while seeking section 510(k) clearance from the U.S. Food and Drug Administration. Tragara currently is using a central laboratory to analyze biomarker data for the phase II trials.
About Capoxigem® (apricoxib, TG01)
Capoxigem (apricoxib, TG01) is an oral, once-daily selective COX-2 inhibitor. It is being evaluated separately for the treatment of inflammation-related pain and cancer. In inflammation-related pain, Capoxigem modulates the cyclooxygenase pathway, ultimately affecting the production of inflammatory prostaglandins. A large phase IIa Proof-of-Concept and dose finding study in inflammation-related pain has been completed in the United States. Superiority to placebo and an active comparator was demonstrated; safety was comparable to the active comparator. As an anti-cancer treatment, Capoxigem affects a number of different oncogenic signaling pathways, including the HIF-1, VEGF, VEGF-R and PDGF systems for angiogenesis; the EGFR, HER2/neu, Bcr/Abl for growth control and differentiation; the intrinsic and extrinsic pathways for apoptosis; and the integrin and metalloproteinase systems for tissue invasion and metastasis. In pre-clinical cancer models, Capoxigem has shown superiority to compounds with similar mechanisms of action and synergy in combination with cisplatin, trastuzumab, and pemetrexed. A phase I study of Capoxigem and erlotinib in NSCLC was conducted to establish the Capoxigem dose regimen for optimal biomarker response with acceptable safety; the combination was well tolerated. Capoxigem is currently in phase II clinical testing for oncology in the United States.
About Tragara
Tragara Pharmaceuticals, Inc. is a privately-held pharmaceutical company based in San Diego, Calif. The company is focused on the clinical and commercial development of proprietary medicines for the treatment of cancer and inflammation. Tragara’s lead therapeutic program, Capoxigem® (apricoxib, TG01), is currently in Phase II clinical development in lung and pancreatic cancers and has completed a phase IIa study in inflammation/pain. A second therapeutic program, TG02, is an oral multi-kinase inhibitor that targets the major signaling pathways involving Flt3, JAK2, ERK5 and several cyclin-dependent kinases (CDKs); TG02 is being prepared for IND filing in Q2 2010. The Company is also developing a “theranostic” product: ProGEM™, a proprietary diagnostic kit for the biomarker being evaluated in the Capoxigem clinical trials. Tragara is managed by a team of entrepreneurs with both Big Pharma and Biotech experience in the development and commercialization of oncology therapeutics. Its investors include: Domain Associates, Mitsubishi International Corporation, Morganthaler Ventures, Oxford BioScience Partners and ProQuest Investments.
Tragara strives to provide much-needed therapies that will contribute to patient health through better survival and an increase in the quality of life. For more information, visit www.tragarapharma.com.
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